Octanoic acid, 1,1'-(1,3-propanediyl) ester

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

The PBT Assessment for Propanediol dicaprylate (CAS 56519-71-2) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

 

Persistence

Propanediol dicaprylate is considered to be readily biodegradable.

According to the Guidance on information requirements and chemical safety assessment Chapter R.11 (PBT assessment, 2012), a substance does not fulfill the criterion “persistent (P)” and very persistent (vP)” if it is readily biodegradable: “If the substance is readily biodegradable, or if the criteria for ready biodegradability are fulfilled with exception of the 10-day window, there is no reason to perform further biodegradation tests for PBT/vPvB assessment. The conclusion is that the substance is not fulfilling the criteria for Persistence (P)”.

The substance is shown to be readily biodegradable in a Manometric Respirometry Test according to OECD guideline 301F with a biodegradation of 75% after 28 days fulfilling the 10-day window criterion. Therefore, the half-life data in the different environmental compartments are expected to be below the cut-off values for persistency given in Annex XIII of Regulation (EC) 1907/2006.

It can be concluded that the substance is not regarded as persistent (P) or very persistent (vP).

  

Bioaccumulation

The bioaccumulation of propanediol dicaprylate is considered to be low.

According to Annex XIII of Regulation (EC) 1907/2006 and according to the Guidance on information requirements and chemical safety assessment Chapter R.11 (PBT assessment, 2012) a substance does not fulfill the criterion “bioaccumulative (B)” or “very bioaccumulative (vB)” if the BCF is below 2000 or the log Kow is below 4.5.

There are no experimental data on BCF available. The experimentally determined log Kow according to OECD 117 is 7.6 and above the screening criterion for the bioaccumulation criterion (log Kow =4.5). However, at very high log Kow (>6), the relationship between log Kow and bioconcentration potential is decreasing. The substance is rapidly metabolised and excreted by organisms and thus an accumulation is not expected. This is supported by calculated low BCF/BAF values (BCF/BAF: 11-11.6 L/kg; Arnot-Gobas estimate, upper trophic). According to Guidance on information requirements and chemical safety assessment (2012) Chapter R.11, Figure R.11-2, no further testing is required to conclude on the Bioaccumulation criterion as “not P” is already confirmed. The substance is not considered to be B or vB.

 

Toxicity

Propanediol dicaprylate is considered to be not toxic.
According to Annex XIII of Regulation (EC) 1907/2006 and according to the Guidance on information requirements and chemical safety assessment (2012) Chapter R.11 PBT assessment a substance does not fulfill the criterion if the long-term NOEC for marine or freshwater organisms is less than 0.01 mg/l and if there is no evidence of chronic toxicity and no classification as carcinogenic (Cat. 1, 2), mutagenic (Cat. 1, 2) or toxic for reproduction (Cat 1, 2, 3) considering human health.
As the substance is not toxic and not classified for human health these criteria are not fulfilled. Furthermore, experimental studies on acute aquatic toxicity on Daphnia and Lemna showed no toxicity up to the limit of water solubility (EC50 > 100mg/l for Lemna based on yield and growth, and the EC50 > 100 mg/l for Daphnia immobilization). Additionally, in a weight of evidence approach on short term toxicity to fish the predicted toxicity was determined to be above water solubility.

A long term toxicity to fish was experimentally assessed and no toxicity was highlighted with a NOEC ≥ 10 mg test item/L.
Finally,a long term aquatic toxicity on daphnia magna was experimentally assessed and no toxicity was highlighted with a NOEC ≥ 10 mg test item/L .
Therefore, according to Guidance R.11 (2012), table R.11-3, it can be concluded that the substance presumably not fulfills the Toxicity criteria of the PBT criteria.

 

Conclusion

In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.